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A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283696
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 13, 2017
First Posted Date  ICMJE September 14, 2017
Last Update Posted Date September 2, 2019
Actual Study Start Date  ICMJE October 18, 2017
Actual Primary Completion Date April 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
Number of Participants with Olaratumab Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Days) ]
Number of participants with olaratumab DLTs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03283696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Pharmacokinetics (PK): Maximum Serum Concentration (Cmax,1) of Olaratumab [ Time Frame: Pre-Dose Day 8 of Cycle 1 through Pre-dose Day 1 Cycle 2 ]
    PK: Cmax of olaratumab
  • PK: Trough Serum Concentration (Cmin,1) of Olaratumab [ Time Frame: Pre-Dose Day 8 of Cycle 1 through Pre-dose Day 1 Cycle 2 ]
    PK: Cmin of olaratumab
  • PK: Maximum Serum Concentration (Cmax,ss) of Olaratumab [ Time Frame: Pre-Dose Day 8 of Cycle 3 through Pre-Dose Day 1 Cycle 4 ]
    PK: Cmax of olaratumab
  • PK: Trough Serum Concentration (Cmin,ss) of Olaratumab [ Time Frame: Pre-Dose Day 8 of Cycle 3 through Pre-Dose Day 1 Cycle 4 ]
    PK: Cmin of olaratumab
  • Number of Participants with Anti-Olaratumab Antibodies [ Time Frame: Baseline through Follow-up (Estimated up to 18 Months) ]
    Number of participants with anti-olaratumab antibodies
  • Objective Response Rate (ORR): Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline up to Short-Term Follow-Up Period (Estimated up to 18 Months) ]
    ORR
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Disease Progression or Death Due to Any Cause (Estimated up to 18 Months) ]
    PFS
  • Duration of Response (DoR) [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Objective Disease Progression or Death Due to Any Cause (Estimated up to 18 Months) ]
    DoR
  • Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) [ Time Frame: Baseline up to Short-Term Follow-up Period (Estimated up to 18 Months) ]
    DCR
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Estimated up to 18 Months) ]
    OS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Official Title  ICMJE A Phase 1b Study of Olaratumab, Doxorubicin and Ifosfamide in the Treatment of Patients With Advanced or Metastatic Soft Tissue Sarcoma
Brief Summary The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Soft Tissue Sarcoma
Intervention  ICMJE
  • Drug: Olaratumab
    Administered IV
    Other Name: LY3012207
  • Drug: Doxorubicin
    Administered IV
  • Drug: Ifosfamide
    Administered IV
  • Drug: Mesna
    Administered per standard of care
Study Arms  ICMJE Experimental: Olaratumab + Doxorubicin + Ifosfamide + Mesna
Olaratumab, doxorubicin and ifosfamide plus mesna administered intravenously (IV).
Interventions:
  • Drug: Olaratumab
  • Drug: Doxorubicin
  • Drug: Ifosfamide
  • Drug: Mesna
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
24
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
60
Actual Study Completion Date  ICMJE August 8, 2019
Actual Primary Completion Date April 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a histological diagnosis of advanced STS (by local pathology review), for which treatment with doxorubicin, ifosfamide and mesna is deemed appropriate by the investigator.
  • Have measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Have adequate hematologic, organ and coagulation function within 2 weeks (14 days) prior to enrollment.
  • Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale.
  • Have received no prior lines of systemic therapy and are suitable to receive doxorubicin, ifosfamide and mesna. All previous anticancer treatments must have completed ≥3 weeks (21 days) prior to the first dose of study treatment.
  • Have left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to enrollment.
  • Have resolution of Adverse Events (AEs), with the exception of alopecia, and of all clinically significant toxic effects of prior locoregional therapy, surgery or radiotherapy to ≤Grade 1, by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
  • Have sufficient available material from archived formalin-fixed paraffin-embedded tumor tissue for biomarker-related studies. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
  • If male, must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of study treatment.
  • If female and of child-bearing potential, must:

    1. have a negative serum pregnancy test at the time of enrollment,
    2. have a negative urine pregnancy test within 24 hours prior to the first dose of study treatment, and
    3. agree to use a highly effective method of contraception during the study and for 3 months following the last dose of study treatment.
  • Have a life expectancy of at least 3 months, in the opinion of the investigator.

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have participated within the past 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
  • Have previously completed or withdrawn from any study investigating olaratumab.
  • Have received prior treatment with olaratumab, doxorubicin, or ifosfamide, or have participated in other trials investigating olaratumab.
  • Have received prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
  • Have known urinary outflow obstruction, or inflammation of the urinary bladder (cystitis).
  • Are diagnosed with gastrointestinal stromal tumor or Kaposi sarcoma.
  • Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of CNS metastasis (previously treated with curative intent [for example, stereotactic radiation or surgery]) that has not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and/or anticonvulsants are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
  • Have a history of another primary malignancy, with the exception of:

    1. curatively treated non-melanomatous skin cancer
    2. curatively treated cervical carcinoma in situ
  • Have an active fungal, bacterial and/or known viral infection including human immunodeficiency virus or viral (A, B, or C) hepatitis (screening is not required).
  • Have Grade 3 or 4 peripheral neuropathy per NCI-CTCAE Version 4.0.
  • Have a serious cardiac condition.
  • Have a resting heart rate of >100 beats per minute (bpm).
  • Have a Fridericia's QT corrected interval (QTcF) interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG) utilizing Fridericia's correction.
  • Have uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics.
  • Have a psychiatric illness/social situation that would limit compliance with study requirements.
  • Have electively planned or will require major surgery during the course of the study.
  • Are females who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03283696
Other Study ID Numbers  ICMJE 16430
I5B-MC-JGDR ( Other Identifier: Eli Lilly and Company )
2016-004287-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP